A study looking at ovarian cancer screening for women at high risk - The United Kingdom Familial Ovarian Cancer Screening Study (UK FOCSS)

This study is looking at screening women who are at a high risk of developing ovarian cancer because they have a family history of cancer of the ovary or breast, or they have family members with a known genetic fault (such as BRCA 1 or BRCA 2).

More than 6,000 women are diagnosed with ovarian cancer in the UK every year. We know that women who have 2 or more close relatives with ovarian cancer or breast cancer may have a higher risk of developing ovarian cancer themselves.

Some women at high risk of developing ovarian cancer will have screening for ovarian cancer. But we don't know yet if screening is helpful or not.

If you are concerned about your risk of developing ovarian cancer because other members of your family have been diagnosed with this or breast cancer, your GP can refer you to a regional genetics centre. If you are thought to be at high risk after the genetics centre have looked at your family history, then you may be able to take part in this trial. Another doctor can also refer you to the regional genetic centre, such as a gynaecologist for example. You may also be able to take part if you are registered with the UK Familial Ovarian Cancer Registry, or a similar registry in another country.

The aim of this trial is to find out whether screening tests can pick up ovarian cancer at an early stage, before it causes symptoms and when treatment is more likely to be successful.

Recruitment

Start 01/06/2002

End 30/03/2010

Phase

Phase 2

Who can enter

You can enter this trial if you

Have a significant family history of ovarian cancer or breast cancer or both (see below)
Are at least 35 years old
Have at least one of your fallopian tubes or ovaries remaining

Defining a significant family history is complicated. The doctors will ask who in your family has been affected by ovarian or breast cancer. Women with a family history of primary peritoneal cancer or fallopian tube cancer rather than ovarian cancer may also be able to take part.

One affected family member has to be your mother, sister or daughter (a first degree relative). The others must each be a first degree relative of another affected family member. So there is a chain of first degree relatives affected by cancer. If you are not sure whether this applies in your family, check with your GP.

The criteria for who can take part in this trial are very complicated. There is more detailed information to explain what the research team means by a significant family history on CancerHelp UK.

You cannot enter this trial if you

Have had both your ovaries and fallopian tubes removed
Are less than 35 years of age
Are taking part in any other ovarian screening studies
Are not considered to be at 'high risk' of developing ovarian cancer

Trial design

This trial will recruit 5,000 women. If your genetic specialist thinks that your family history of cancer means you can join this trial, you will have counselling about the benefits and risks of taking part. This will include information about the limitations of screening and the risks involved. For example, you could get a positive screening result when you do not have ovarian cancer (this is called a false positive result). This can cause anxiety and may mean you have unnecessary treatment.

All those taking part in this trial will have a blood test for the CA125 tumour marker 3 times a year for up to 4 years (exactly how long will depend on when you join the trial). These blood tests can be done by the practice nurse at your GP surgery. Or, if your GP surgery does not take blood samples, at your local hospital. You may have more blood tests if the research team think you need them. They will also ask you if they can store some of the blood sample to be used for future research.

You will also have an ultrasound scan that is done using a probe inserted into the vagina (transvaginal ultrasound scan). This will be done every year for up to 4 years (exactly how long will depend on when you join the trial). You may need an ultrasound scan more often than this, depending on your CA125 test results.

If any of the test results show something abnormal in your ovaries, you will be referred to a gynaecologist for further assessment. Any treatment will then be given as needed.

There is more information about this study on the Institute for Women's Health website.

Hospital visits

You will visit one of the hospitals involved in the trial before you enter the study. You will then go to hospital for an ultrasound scan at least once a year (you may need to go more often if the doctors think you need another scan).

Every four months, you will be sent a pack by the study coordinating centre, containing everything you need to have the blood sample taken. You will need to take this pack to your GP surgery or local hospital and ask them to take the blood sample.

Side effects

There are no side effects in this trial, apart from the needle pricks for the blood tests. Ultrasound scans use sound waves and do not have side effects.

If the tests show something abnormal in your ovaries, you may need further treatment.

There is information on the treatment of ovarian cancer and on treatment side effects in the Ovarian Cancer section of CancerHelp UK.